NL-OMON35560已完成2 期
A Phase II Study to Evaluate: Delay in Intravaginal Ejaculatory Latency Time (IELT), Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Two Oral Doses of GSK557296 in a Randomized, Double Blind, Placebo-Controlled, Parallel Group Study in Men with Premature Ejaculation - A Phase II study with GSK557296 in men with premature ejaculation.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Males with primary PE, according to the ISSM Consensus Definition.
- •2. Stable heterosexual relationship.
- •3. Aged between 18 and 54 years.
- •4. The subject must make at least four attempts at sexual intercourse on four separate days during the untreated run in period.
- •5. The average intravaginal ejaculatory latency time must be < 65 seconds based on the study-provided stop watch assessments.
排除标准
- •Erectile dysfunction (defined as IIEF-EF domain score < 22).
- •Active or recent (< 6 months) history of prostatitis.
- •Presence of penile anatomical abnormalities.
- •Prior implantation of penile implant for erectile dysfunction.
- •Primary hypoactive sexual desire.
- •Spinal cord injury.
- •History of seizures, within last 6 months.
- •History of prostate cancer treated or untreated.
- •History of prostatectomy or prostate procedures for any cause.
- •Cardiac arrhythmia.
- •Any condition which would preclude sexual activity.
- •Labvalues outside normal range.
研究者
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